Orilissa — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has a diagnosis of moderate to severe pain associated with endometriosis
• The patient is premenopausal (e.g., less than 12 months since last menstrual period)
• ONE of the following: • The patient has tried and had an inadequate response to ONE prerequisite agent (i.e., hormonal contraceptive, NSAID [including COX-II inhibitors]) used in the treatment of the requested indication OR • The patient has an intolerance or hypersensitivity to ONE prerequisite agent (i.e., hormonal contraceptive, NSAID [including COX-II inhibitors]) used in the treatment of the requested indication OR • The patient has an FDA labeled contraindication to ALL prerequisite therapies (i.e., hormonal contraceptives [oral, topical patches, implants, injections, IUD], NSAIDs [including COX-II inhibitors]) used in the treatment of the requested indication
• The patient’s bone health has been assessed AND allows for initiating therapy with the requested agent
• The patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (e.g., elagolix, relugolix) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent
• ONE of the following: • The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh [CP]/Child-Turcotte-Pugh [CTP] Class B) AND ONE of the following: – The patient is initiating therapy with the requested agent and strength OR – The patient is not initiating therapy with the requested agent and strength and BOTH of the following: ▪ There is support confirming the number of months the patient has been on therapy ▪ ONE of the following: ◦ The requested strength is 150 mg AND the total duration of treatment with the requested strength has NOT exceeded 24 months per lifetime OR ◦ The requested strength is 200 mg AND the total duration of treatment with the requested strength has NOT exceeded 6 months per lifetime OR • The patient does have coexisting moderate hepatic impairment (Child-Pugh [CP]/Child-Turcotte-Pugh [CTP] Class B) AND BOTH of the following: – The requested strength is 150 mg AND – ONE of the following: ◦ The patient is initiating therapy with the requested agent and strength OR ◦ The patient is not initiating therapy with the requested agent and strength AND BOTH of the following: ▪ There is support confirming the number of months the patient has been on therapy ▪ The total duration of treatment with the requested strength has NOT exceeded 6 months per lifetime

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process (requests for 200 mg strength should always be reviewed under initial criteria)
• The patient is premenopausal (e.g., less than 12 months since last menstrual period)
• The patient has had clinical benefit with the requested agent
• The patient’s bone health has been assessed AND allows for continued therapy with the requested agent
• The patient has NOT had a fragility fracture since starting therapy with the requested agent
• The patient will NOT be using the requested agent in combination with another GnRH antagonist agent targeted in this program (e.g., elagolix, relugolix) for the requested indication
• The patient does NOT have any FDA labeled contraindications to the requested agent
• BOTH of the following: • There is support confirming the number of months the patient has been on therapy with the requested agent and strength • ONE of the following: – The patient does NOT have coexisting moderate hepatic impairment (Child-Pugh [CP]/Child-Turcotte-Pugh [CTP] Class B) AND the total duration of treatment with the requested strength has NOT exceeded 24 months per lifetime OR – The patient does have coexisting moderate hepatic impairment (Child-Pugh [CP]/Child-Turcotte-Pugh [CTP] Class B) AND the total duration of treatment with the requested strength has NOT exceeded 6 months per lifetime

Approval duration

6 months (lifetime max 24 months for 150 mg without hepatic impairment; 6 months with impairment or 200 mg)